Cleared Traditional

K113760 - VARIAX SUPERIOR AND ANTERIOR, LATERAL AND MIDSHAFT CLAVICLE PLATES VARIAX AIMING BLOCKS & JOYSTICK

K113760 is an FDA 510(k) clearance for VARIAX SUPERIOR AND ANTERIOR, manufactured by Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K113760 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
126d
Days
Class 2
Risk

K113760 is an FDA 510(k) clearance for the VARIAX SUPERIOR AND ANTERIOR, LATERAL AND MIDSHAFT CLAVICLE PLATES VARIAX AIM.... Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp., Dba Stryker Orthopaedics (Mahwah, US). The FDA issued a Cleared decision on April 25, 2012 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Howmedica Osteonics Corp., Dba Stryker Orthopaedics devices

FDA 510(k) Submission Details - K113760

510(k) Number K113760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2011
Decision Date April 25, 2012
Days to Decision 126 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 122d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HRS Plate, Fixation, Bone

All 1226
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K113760.
ORTHOLOC 3DI HALLUX SYSTEM
K120359 · Wrightmedicaltechnologyinc · May 2012
MICROWARE BONE PLATES AND BONE SCREW
K111008 · Microware Precision Co., Ltd. · May 2012
APTUS PROXIMAL HUMERUS SYSTEM
K120108 · Medartis AG · Apr 2012
OSTEOMED WRIST PLATING SYSTEM
K120015 · Osteomed LP · Apr 2012
OTIS-C PLUS
K120818 · Science For Biomaterials · Apr 2012
MINI MAXLOCK EXTREME PLATING SYSTEM
K120157 · Orthohelix Surgical Designs, Inc. · Apr 2012